Protocol summary

Summary
The objective of this study is to assess the efficacy of Pentoxifylline in the treatment of autism. Fourty children between the ages 3 and 11 years (inclusive) with a DSM IV clinical diagnosis of autism and who will be outpatients from a specialty clinic for children will be recruited. The children should present with a chief complaint of severely disruptive symptoms related to autistic disorder. Patients will be randomly allocated into Pentoxifylline (200- 400 mg/day) + Risperidone (3.5mg/day) or Placebo + Risperidone (3.5mg/day) for a 10-week, double-blind, placebo-controlled study. Patients will be assessed at baseline and after 2, 4, 6, 8 and 10 weeks of starting medication. The primary outcome measure is the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (total score).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138711161556N7
Registration date: 2009-03-13, 1387/12/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2009-03-13, 1387/12/23
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2007-04-20, 1386/01/31
Expected recruitment end date
2009-04-20, 1388/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double- blind placebo controlled trial of Pentoxifylline added to Risperidone in patients with autistic disorders
Public title
Pentoxifylline in the treatment of autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: DSM IV clinical diagnosis of autism, children and adolescents between the ages of 3 and 11 years (inclusive), Exclusion Criteria: Presence of any active medical problem, any diagnosis in Axis I and II except for mental retatdation, history of allergy to Pentoxifylline, receiving any psychotropic medications during past two weeks prior to the trial, presence of aggressive behavior that needs Risperidone
Age
From 3 years old to 11 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2007-04-20, 1386/01/31
Ethics committee reference number
5401

Health conditions studied

1

Description of health condition studied
Childhood autism
ICD-10 code
F84.0
ICD-10 code description
Childhood autism

Primary outcomes

1

Description
Severity of Autism
Timepoint
Baseline and weerks 2, 4, 6, 8, 10
Method of measurement
Aberrant Behavior Checklist-Community (ABC-C) Rating Scale

Secondary outcomes

empty

Intervention groups

1

Description
Tablet Pentoxifylline 400 mg/day+ Tablet Risperidon 1-3.5 mg as intervention
Category
Treatment - Drugs

2

Description
Tablet Risperidone 1-3.5 mg/day +Tablet Placebo as control
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh Psychiatry Hospital
Full name of responsible person
Dr. Mohhamad Reza Mohhamadi
Street address
Roozbeh Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Foutohi
Street address
Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
5401
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology, Ph.D.
Other areas of specialty/work
Street address
Roozbeh Hospital
City
Tehran
Postal code
13337
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clonical Psychopharmacology, Ph.D.
Other areas of specialty/work
Street address
Roozbeh Hospital
City
Tehran
Postal code
13337
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tuma.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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